Exploratory Study on Quality of Life in Patient With Moderate Psoriasis and Moderate Psoriatic Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 10
- 主要终点
- There is no primary outcome in this study. See objectives.
研究概览
简要总结
This exploratory study will be used to identify questions that will be part of a new QoL questionnaire for patients with psoriasis and psoriatic arthritis and to determine the sample size needed for its validation. The new questionnaire will be a global QoL questionnaire which will take into account the impact of both psoriasis and psoriatic arthritis on QoL.
STUDY OBJECTIVES
- To evaluate the influence of psoriasis and psoriatic arthritis on patient's answers to QoL questions from DLQI, HAQ, EQ-5D, FACIT-fatigue and SF-36.
- To identify an equal number of questions from DLQI, HAQ, EQ-5D, FACIT-fatigue and SF-36 where answers are mostly influenced either by psoriatic arthritis or by psoriasis.
详细描述
This study will recruit three cohorts of 40 patients each: moderate psoriatic arthritis and moderate psoriasis, mild psoriatic arthritis and moderate psoriasis, moderate psoriatic arthritis and mild psoriasis. Eligible patients will fill the following questionnaires: Dermatology Life Quality Index (DLQI), Health Assessment Questionnaire (HAQ), EQ-5D, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) and 36-Item Short Form Health Survey Questionnaire (SF-36). In addition, each patient will be asked on a 4 point Likert scale how much their answer to each question is related to the impact of their skin disease or their psoriatic arthritis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with plaque psoriasis and psoriatic arthritis with either:
- •Moderate psoriatic arthritis and moderate psoriasis defined as: [psoriatic arthritis with either 3-7 joints showing signs of synovitis OR a BASDAI of 2-4] AND [between 3 to less than 10% of the body surface area involved with psoriasis] (COHORT A) OR
- •Mild psoriatic arthritis and Moderate psoriasis defined as: [psoriatic arthritis with either 1-2 joints showing signs of synovitis OR a BASDAI greater than 0 but less than 2] AND [between 3 to less than 10% of the body surface area involved with psoriasis] (COHORT B) OR
- •Moderate psoriatic arthritis and Mild psoriasis defined as: [psoriatic arthritis with either 3-7 joints showing signs of synovitis OR a BASDAI of 2-4] AND [more than 0 but less than 3% of the body surface area involved with psoriasis] (COHORT C)
- •Patient is between 18 years and older.
- •Patient is capable of reading and understanding French or English questionnaires.
- •Patient is capable of giving informed consent.
排除标准
- •Patient has presence of eythrodermic, pustular or guttate psoriasis.
- •Patient has another non psoriatic arthropathy (such as osteoarthritis) that could have a significant impact of QoL related to psoriatic arthritis
- •Patient has another non psoriatic dermatosis that could have a significant impact on QoL related to psoriasis
- •Patient has any other co-morbidity with a severity that could have a significant impact on QoL
- •Patient has had a significant flare-up of psoriasis or psoriatic arthritis within 90 days of Day 0
- •Patient has received investigational drugs within four weeks prior to Day 0
- •Patient has been treated with systemic anti-psoriatic drugs such as steroids, retinoids, cyclosporine, PUVA therapy within the four weeks prior to Day
- •Methotrexate, sulphasalazine and leflunomide are allowed during the study as long as patient has been on a stable dose within 90 days of Day
- •Patient has been treated with ultraviolet light therapy (UVB, nbUVB) within the two weeks prior to Day 0
- •Patient has used biologics (such etanercept, adalimumab, infliximab, abatacept, ustekinumab) within 180 days of Day 0
- •Patient is currently pregnant or lactating.
结局指标
主要结局
There is no primary outcome in this study. See objectives.
时间窗: 1 Day
There is no primary outcome in this study. Patients with psoriatic arthritis and psoriasis answer questionnaires on one occasion.
次要结局
未报告次要终点